MedDataX Logo

Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

NCT ID: NCT00134771

Last Updated: 2005-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2003-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.

Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Birth Weight

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Infants whose birthweight is less than the 20th centile for gestational age (UK standards) Infants who are formula fed from birth Singletons Infants free from major congenital disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutrient enriched infant formula

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants who are formula fed from birth
* Infants whose birthweights are less than 20th centile
* Singleton births
* Gestation \> 37 weeks
* Infants free from major congenital disease

Exclusion Criteria

* Infants who are breast-fed
* Multiple births
* Birthweight \> 20th centile
* Infants with congenital disease
* Gestation \< 37 weeks
Minimum Eligible Age

0 Years

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute of Child Health

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Atul Singhal

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Neonatal Unit, Wishaw Hospital, 50 Netherton St

Wishaw, Lanrkshire, United Kingdom

Site Status

The Queen Mother's Hospital, Yorkhill

Glasgow, , United Kingdom

Site Status

Maternity Hospital, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Maternity Unit, Southern General Hospital, 1345 Govan Road

Glasgow, , United Kingdom

Site Status

MRC Childhood Nutrition Research Centre, Inst of Child Health

London, , United Kingdom

Site Status

Maternity Unit, Royal Alexandra Hospital, Corsebar Road

Paisley, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

99/2/109

Identifier Type: -

Identifier Source: org_study_id